MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANNULATED DRILL TUBE; INSTRUMENT, STEREOTAXIC

Model Number	9733140
Medical Device Problem Codes	Imprecision (1307); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the cannulated drill tube was damaged resulting in the instrument model not appearing in the proper location on the application software.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the behavior described is the intended behavior of the software.Software is functioning as designed.Analysis found that the software functioned as designed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CANNULATED DRILL TUBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8102740
• Report Number: 1723170-2018-05835
• Device Sequence Number: 16643033
• Product Code: HAW
• UDI-Device Identifier: 00613994258830
• UDI-Public: 00613994258830
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9733140
• Device Catalogue Number: 9733140
• Device Lot Number: 160209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/30/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1